The goal of this interventional study is to determine pathological complete response (pCR) after neoadjuvant chemotherapy (NAC) and Efti treatment. This is a prospective single arm interventional trial in patients with early-stage HR+/HER2 -ve breast cancer (Stage I-III) who are eligible for neoadjuvant chemotherapy (NAC). Enrolled patients will be treated with single agent efti for 3 weeks and then start NAC in combination with efti. There are 2 standard NAC usually used and will be determined by treating physician prior to starting on this trial.
Have histologically documented HR+/HER2 neg (defined as ER expression >10% by IHC and/or PR expression > 10% by IHC and HER2 0 or 1+ or 2+ by IHC or FISH ratio <2 or HER2 gene copy number of <6).
Clinical early-stage breast cancer (Stage I-III) and a candidate for NAC.
Be informed of the investigational nature of the trial and all pertinent aspects of the trial.
Have ECOG performance status of 0-2.
Receiving concurrent anti-neoplastic therapy for another malignancy
Known documented or suspected hypersensitivity to the components of the trial drug or analogs.
Stage IV or patients otherwise not indicated for surgery. Patients with oligometastatic disease who are undergoing curative intent treatment are eligible as long as curative intent surgery is planned.
A woman of child-bearing potential who has a positive serum pregnancy test (within 72 hours) prior to Day 1.
Single group
Eftilagimod Alfa (Efti)
DrugEftilagimod Alfa (Efti) will be administered subcutaneously at a dose of 30 mg beginning of week 1 of the trial for a total of 3 doses (week 1, 2 and 3). After 3 weeks, efti will be administered starting with week 4, every 2 weeks and combined with either TC or AC
Docetaxel-cyclophosphamide (TC) intravenous (i.v)
DrugTC will be administered at docetaxel 75mg/m2 IV and cyclophosphamide 600mg/m2 IV every 3 weeks for a total of 4 administrations starting on week 4 of the trial (weeks 4, 7,10, and 13). Docetaxel is administered over 60min (dilute in 250 mL NS or D5W to a final concentration of 0.3 to 0.74 mg/mL and administer over 60 minutes). Cyclophosphamide is administered over 30-60min (dilute in 250 to 500 mL NS or D5W and administer over 30 to 60 minutes after docetaxel). G-CSF support for TC is per institutional SOC guidelines. Efti is to be given always ≥ 30 minutes after TC is finished if both regimens are administered the same day.
Dose dense Adriamycin-cyclophosphamide (AC) i.v
DrugAC will be administered at doxorubicin 60mg/m2 and cyclophosphamide 600mg/m2 IV every 2 weeks for a total of 4 administrations starting week 4 of the trial (weeks 4, 6, 8 and 10): Doxorubicin is administered over 5 min (Dilute with NS to a final concentration of 2 mg/mL and administered as an IV bolus over three to five minutes into a free flowing IV infusion of NS or D5W). Cyclophosphamide is administered over 30-60min (Dilute in 250 to 500 mL NS or D5W and administer over 30 to 60 minutes). G-CSF support is per SOC/institutional guidelines. Paclitaxel is given weekly for a period of 12 weeks (weeks 12 to 23) at 80mg/m2 (Dilute with 250 to 500 mL NS or D5W (final concentration of 0.3 to 1.2 mg/mL) and administered per institutional guidelines). Alternatively nab-paclitaxel weekly can be used (if paclitaxel cannot be used due to allergic reaction). Efti is to be given always ≥ 30 minutes after AC or paclitaxel is finished if both regimens are administered the same day.
To determine pathological complete response (pCR) after neoadjuvant chemotherapy (NAC) and Efti treatment
The number of pathological complete responses determined in surgical pathology report. The primary endpoint is pCR to NAC + efti. Simon's 2-stage design will be used. The null hypothesis that the true pCR rate is 0.08 (8%) will be tested against a one-sided alternative. In the first stage, 30 patients will be accrued. If there are 2 or fewer responses in these 30 patients, the study will be stopped. Otherwise, 20 additional patients will be accrued for a total of 50. The null hypothesis will be rejected if 8 or more responses are observed in 50 patients. This design yields a type I error rate of 0.0426 and power of 0.80 when the true pCR rate is 0.20 (20%).
To determine clinical response to Efti + NAC.
Clinical response is determined by clinical/imaging measurements of the tumor performed at baseline, during and end of treatment phase. Complete clinical response is defined as no measurable disease per imaging and by exam. Partial response is defined as \> 15% decrease in baseline measurements by clinical/imaging to complete response criteria (as above) Stable disease is defined as no change in measurements by clinical/imaging +/- 15% . Progressive disease is defined as increase in clinical/imaging measurement by 15% of baseline measurements or development of a new mass/lesion. The % of patients in each response category will be reported as a descriptive measure. .
To determine change in tumor's Ki67
Compare baseline tumor's Ki67 to that in residual tumor after surgical resection. Wilcoxon signed-rank test be done to compare change in Ki67 between 2 specimens for tumors which have residual disease at time of surgery.
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George Washington University
Lead sponsor
Immutep S.A.S.
Collaborator
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